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510(k) K801276

DUPONT PREP APPLI. FOR PHENOBARBITAL, by E.I. Dupont DE Nemours & Co., Inc. — Product Code DKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1980
Date Received
May 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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Other clearances for product code DKH

  • K780733 — ANTICONVULSANTS III CALIBRATOR KIT (June 22, 1978)